Multi-mode electrical stimulation systems and methods of making and using

ABSTRACT

Methods and systems can facilitate identifying effective electrodes and other stimulation parameters, as well as determining whether to use cathodic and anodic stimulation. Alternately, the methods and systems may identify effective electrodes and other stimulation parameters based on preferential stimulation of different types of neural elements. These methods and systems can further facilitate programming an electrical stimulation system for stimulating patient tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. § 119(e) of U.S.Provisional Patent Application Ser. No. 62/663,908, filed Apr. 27, 2018,which is incorporated herein by reference.

FIELD

The present disclosure is directed to the area of implantable electricalstimulation systems and methods of making and using the systems. Thepresent disclosure is also directed to electrical stimulation systemswith multiple modes, such as anodic or cathodic stimulation modes, andmethods of making and using.

BACKGROUND

Implantable electrical stimulation systems have proven therapeutic in avariety of diseases and disorders. For example, spinal cord stimulationsystems have been used as a therapeutic modality for the treatment ofchronic pain syndromes. Peripheral nerve stimulation has been used totreat chronic pain syndrome and incontinence, with a number of otherapplications under investigation. Functional electrical stimulationsystems have been applied to restore some functionality to paralyzedextremities in spinal cord injury patients. Stimulation of the brain,such as deep brain stimulation, can be used to treat a variety ofdiseases or disorders.

Stimulators have been developed to provide therapy for a variety oftreatments. A stimulator can include a control module (with a pulsegenerator), one or more leads, and an array of stimulator electrodes oneach lead. The stimulator electrodes are in contact with or near thenerves, muscles, or other tissue to be stimulated. The pulse generatorin the control module generates electrical pulses that are delivered bythe electrodes to body tissue.

BRIEF SUMMARY

One aspect is a system for programming electrical stimulation of apatient using an implantable electrical stimulation system including animplantable pulse generator and a lead having a plurality of electrodes.The system includes a processor configured to receive a first responsefor each of a plurality of first monopolar stimulations performed usinga subset of one or more of the electrodes of the lead as a cathode foreach of the first monopolar stimulations; select a first subset of oneor more of the electrodes based on the first responses; receive a secondresponse for each of a plurality of second monopolar stimulationsperformed using a subset of one or more of the electrodes of the lead asan anode for each of the second monopolar stimulations; select a secondsubset of one or more of the electrodes based on the second responses;select a programming subset of one or more of the electrodes based, atleast in part, on the responses associated with the first subset andsecond subset; receive a third response for each of a plurality of thirdmonopolar stimulations performed using the programming subset with eachof the third monopolar stimulation having a different stimulationamplitude; select a programming stimulation amplitude based on the thirdresponses; receive direction to program the implantable pulse generatorwith the programming subset of one or more of the electrodes and theprogramming stimulation amplitude; and initiate a signal that providesthe implantable pulse generator of the electrical stimulation systemwith the programming subset of one or more of the electrodes and theprogramming stimulation amplitude for generating electrical stimulationfor the patient through the electrodes of the lead.

Another aspect is a method for programming electrical stimulation of apatient using an implantable electrical stimulation system including animplantable pulse generator and a lead having a plurality of electrodes.The method includes receiving a first response for each of a pluralityof first monopolar stimulations performed using a subset of one or moreof the electrodes of the lead as a cathode for each of the firstmonopolar stimulations; selecting a first subset of one or more of theelectrodes based on the first responses; receiving a second response foreach of a plurality of second monopolar stimulations performed using asubset of one or more of the electrodes of the lead as an anode for eachof the second monopolar stimulations; selecting a second subset of oneor more of the electrodes based on the second responses; selecting aprogramming subset of one or more of the electrodes based, at least inpart, on the responses associated with the first subset and secondsubset; receiving a third response for each of a plurality of thirdmonopolar stimulations performed using the programming subset with eachof the third monopolar stimulation having a different stimulationamplitude; selecting a programming stimulation amplitude based on thethird responses; receiving direction to program the implantable pulsegenerator with the programming subset of one or more of the electrodesand the programming stimulation amplitude; and initiating a signal thatprovides the implantable pulse generator of the electrical stimulationsystem with the programming subset of one or more of the electrodes andthe programming stimulation amplitude for generating electricalstimulation for the patient through the electrodes of the lead.

A further aspect is non-transitory computer-readable medium havingcomputer executable instructions stored thereon that, when executed by aprocessor, cause the processor to perform the method described above.

In at least some aspects, receiving a first response includes receivinga first quantitative or qualitative indication of at least onetherapeutic effect and receiving a second response includes receiving asecond quantitative or qualitative indication of at least onetherapeutic effect. In at least some aspects, receiving a first responseincludes receiving a first quantitative or qualitative indication of atleast one therapeutic effect, at least one side-effect, or anycombination thereof and receiving a second response includes receiving asecond quantitative or qualitative indication of at least onetherapeutic effect, at least one side-effect, or any combinationthereof. In at least some aspects, selecting the set of programstimulation parameters includes selecting the set of program stimulationparameters based on the first and second quantitative or qualitativeindications.

In at least some aspects, the processor is further configured to, or themethod further includes steps to, receive a third response for each of aplurality of cathodic/anodic stimulations performed using a subset ofone or more of the electrodes of the lead as an anode and one or more ofthe electrodes of the lead as a cathode for each of the cathodic/anodicstimulations; and select a third subset of one or more of the electrodesbased on the third responses; wherein selecting the programming subsetof one or more of the electrodes includes selecting the programmingsubset of one or more of the electrodes based, at least in part, on thefirst, second, and third responses associated with the first subset,second subset, and third subset.

In at least some aspects, receiving a first response including receivingthe first response from a clinician or patient. In at least someaspects, receiving a first response including receiving the firstresponse from a sensor.

Another aspect is a system for programming electrical stimulation of apatient using an implantable electrical stimulation system including animplantable pulse generator and a lead having a plurality of electrodes.The system includes a processor configured to receive a first responsefor each of a plurality of first stimulations performed using a subsetof one or more of the electrodes of the lead for each of the firststimulations, wherein the first stimulations are configured topreferentially stimulate a first type of neural element; select a firstsubset of one or more of the electrodes based, at least in part, on thefirst responses; receive a second response for each of a plurality ofsecond stimulations performed using a subset of one or more of theelectrodes for each of the second stimulations, wherein the secondstimulations are configured to preferentially stimulate a second type ofneural element which is different from the first type of neural element;select a second subset of one or more of the electrodes based, at leastin part, on the second responses; select a programming subset of one ormore of the electrodes based on the responses associated with the firstsubset and second subset; receive direction to program the implantablepulse generator with the programming subset of one or more of theelectrodes and the programming stimulation amplitude; and initiate asignal that provides the implantable pulse generator of the electricalstimulation system with the programming subset of one or more of theelectrodes and the programming stimulation amplitude for generatingelectrical stimulation for the patient through the electrodes of thelead.

Yet another aspect is a method for programming electrical stimulation ofa patient using an implantable electrical stimulation system includingan implantable pulse generator and a lead having a plurality ofelectrodes. The method includes receiving a first response for each of aplurality of first stimulations performed using a subset of one or moreof the electrodes of the lead for each of the first stimulations,wherein the first stimulations are configured to preferentiallystimulate a first type of neural element; selecting a first subset ofone or more of the electrodes based, at least in part, on the firstresponses; receiving a second response for each of a plurality of secondstimulations performed using a subset of one or more of the electrodesfor each of the second stimulations, wherein the second stimulations areconfigured to preferentially stimulate a second type of neural elementwhich is different from the first type of neural element; selecting asecond subset of one or more of the electrodes based, at least in part,on the second responses; selecting a programming subset of one or moreof the electrodes based on the responses associated with the firstsubset and second subset; receiving direction to program the implantablepulse generator with the programming subset of one or more of theelectrodes and the programming stimulation amplitude; and initiating asignal that provides the implantable pulse generator of the electricalstimulation system with the programming subset of one or more of theelectrodes and the programming stimulation amplitude for generatingelectrical stimulation for the patient through the electrodes of thelead.

A further aspect is non-transitory computer-readable medium havingcomputer executable instructions stored thereon that, when executed by aprocessor, cause the processor to perform the method described above.

In at least some aspects, receiving a first response includes receivinga first quantitative or qualitative indication of at least onetherapeutic effect and receiving a second response includes receiving asecond quantitative or qualitative indication of at least onetherapeutic effect. In at least some aspects, receiving a first responseincludes receiving a first quantitative or qualitative indication of atleast one therapeutic effect, at least one side-effect, or anycombination thereof and receiving a second response includes receiving asecond quantitative or qualitative indication of at least onetherapeutic effect, at least one side-effect, or any combinationthereof. In at least some aspects, selecting the set of programstimulation parameters includes selecting the set of program stimulationparameters based on the first and second quantitative or qualitativeindications.

In at least some aspects, the processor is further configured to, or themethod further includes steps to, receive a third response for each of aplurality of third stimulations performed using a subset of one or moreof the electrodes for each of the third stimulations, wherein the thirdstimulations are configured to preferentially stimulate a third type ofneural element which is different from the first and second types ofneural element; and select a third subset of one or more of theelectrodes based, at least in part, on the third responses; whereinselecting the programming subset of one or more of the electrodesincludes selecting the programming subset of one or more of theelectrodes based, at least in part, on the first, second, and thirdresponses associated with the first subset, second subset, and thirdsubset.

In at least some aspects, receiving a first response including receivingthe first response from a clinician or patient. In at least someaspects, receiving a first response including receiving the firstresponse from a sensor.

Another aspect is a system for programming electrical stimulation of apatient using an implantable electrical stimulation system including animplantable pulse generator and a lead having a plurality of electrodes.The system includes a processor configured to receive a first responsefor each of a plurality of first monopolar stimulations performed usingat least one of the electrodes of the lead as a cathode, each of thefirst monopolar stimulations having a set of first stimulationparameters associated with the first stimulation; receive a secondresponse for each of a plurality of second monopolar stimulationsperformed using at least one of the electrodes of the lead as an anode,each of the second monopolar stimulations having a set of secondstimulation parameters associated with the second stimulation; select,from the sets of first stimulation parameters and sets of secondstimulation parameters, a set of program stimulation parameters for afirst stimulation program based on the first and second responses;receive direction to program the implantable pulse generator with theset of program stimulation parameters; and initiate a signal thatprovides the implantable pulse generator of the electrical stimulationsystem with the set of program stimulation parameters for generatingelectrical stimulation for the patient through the electrodes of thelead.

Yet another aspect is a method for programming electrical stimulation ofa patient using an implantable electrical stimulation system includingan implantable pulse generator and a lead having a plurality ofelectrodes. The method includes receiving a first response for each of aplurality of first monopolar stimulations performed using at least oneof the electrodes of the lead as a cathode, each of the first monopolarstimulations having a set of first stimulation parameters associatedwith the first stimulation; receiving a second response for each of aplurality of second monopolar stimulations performed using at least oneof the electrodes of the lead as an anode, each of the second monopolarstimulations having a set of second stimulation parameters associatedwith the second stimulation; selecting, from the sets of firststimulation parameters and sets of second stimulation parameters, a setof program stimulation parameters for a first stimulation program basedon the first and second responses; receiving direction to program theimplantable pulse generator with the set of program stimulationparameters; and initiating a signal that provides the implantable pulsegenerator of the electrical stimulation system with the set of programstimulation parameters for generating electrical stimulation for thepatient through the electrodes of the lead.

A further aspect is non-transitory computer-readable medium havingcomputer executable instructions stored thereon that, when executed by aprocessor, cause the processor to perform the method described above.

In at least some aspects, receiving a first response includes receivinga first quantitative or qualitative indication of at least onetherapeutic effect and receiving a second response includes receiving asecond quantitative or qualitative indication of at least onetherapeutic effect. In at least some aspects, receiving a first responseincludes receiving a first quantitative or qualitative indication of atleast one therapeutic effect, at least one side-effect, or anycombination thereof and receiving a second response includes receiving asecond quantitative or qualitative indication of at least onetherapeutic effect, at least one side-effect, or any combinationthereof. In at least some aspects, selecting the set of programstimulation parameters includes selecting the set of program stimulationparameters based on the first and second quantitative or qualitativeindications.

In at least some aspects, receiving a first response including receivingthe first response from a clinician or patient. In at least someaspects, receiving a first response including receiving the firstresponse from a sensor.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the present invention aredescribed with reference to the following drawings. In the drawings,like reference numerals refer to like parts throughout the variousfigures unless otherwise specified.

For a better understanding of the present invention, reference will bemade to the following Detailed Description, which is to be read inassociation with the accompanying drawings, wherein:

FIG. 1 is a schematic view of one embodiment of an electricalstimulation system;

FIG. 2 is a schematic side view of one embodiment of an electricalstimulation lead;

FIG. 3 is a schematic block diagram of one embodiment of a system fordetermining stimulation parameters;

FIG. 4A is a flowchart of one embodiment of a method for programmingelectrical stimulation of a patient;

FIG. 4B is a flowchart of additional steps that can be added to theflowchart of FIG. 4A;

FIG. 5A is a flowchart of another embodiment of a method for programmingelectrical stimulation of a patient;

FIG. 5B is a flowchart of additional steps that can be added to theflowchart of FIG. 5A;

FIG. 6A is a flowchart of a third embodiment of a method for programmingelectrical stimulation of a patient;

FIG. 6B is a flowchart of additional steps that can be added to theflowchart of FIG. 6A;

FIG. 7 is a flowchart of one embodiment of a method obtainingstimulation parameters that can be used in conjunction with theflowcharts of FIGS. 4A to 6B; and

FIG. 8 is a flowchart of one embodiment of a method generate a graph ofresponse to stimulations that can be used in conjunction with theflowcharts of FIGS. 4A to 6B.

DETAILED DESCRIPTION

The present disclosure is directed to the area of implantable electricalstimulation systems and methods of making and using the systems. Thepresent disclosure is also directed to electrical stimulation systemswith multiple modes, such as anodic or cathodic stimulation modes, andmethods of making and using.

Suitable implantable electrical stimulation systems include, but are notlimited to, a least one lead with one or more electrodes disposed on adistal end of the lead and one or more terminals disposed on one or moreproximal ends of the lead. Leads include, for example, percutaneousleads, paddle leads, cuff leads, or any other arrangement of electrodeson a lead. Examples of electrical stimulation systems with leads arefound in, for example, U.S. Pat. Nos. 6,181,969; 6,516,227; 6,609,029;6,609,032; 6,741,892; 7,244,150; 7,450,997; 7,672,734;7,761,165;7,783,359; 7,792,590; 7,809,446; 7,949,395; 7,974,706; 8,175,710;8,224,450; 8,271,094; 8,295,944; 8,364,278; 8,391,985; and 8,688,235;and U.S. Patent Applications Publication Nos. 2007/0150036;2009/0187222; 2009/0276021; 2010/0076535; 2010/0268298; 2011/0005069;2011/0004267; 2011/0078900; 2011/0130817; 2011/0130818; 2011/0238129;2011/0313500; 2012/0016378; 2012/0046710; 2012/0071949; 2012/0165911;2012/0197375; 2012/0203316; 2012/0203320; 2012/0203321; 2012/0316615;2013/0105071; and 2013/0197602, all of which are incorporated byreference. In the discussion below, a percutaneous lead will beexemplified, but it will be understood that the methods and systemsdescribed herein are also applicable to paddle leads and other leads.

A percutaneous lead for electrical stimulation (for example, deep brainor spinal cord stimulation) includes stimulation electrodes that can bering electrodes, segmented electrodes that extend only partially aroundthe circumference of the lead, or any other type of electrode, or anycombination thereof. The segmented electrodes can be provided in sets ofelectrodes, with each set having electrodes circumferentiallydistributed about the lead at a particular longitudinal position. Forillustrative purposes, the leads are described herein relative to usefor deep brain stimulation, but it will be understood that any of theleads can be used for applications other than deep brain stimulation,including spinal cord stimulation, peripheral nerve stimulation, orstimulation of other nerves, muscles, and tissues. In particular,stimulation may stimulate specific targets. Examples of such targetsinclude, but are not limited to, the subthalamic nucleus (STN), internalsegment of the globus pallidus (GPi), external segment of the globuspallidus (GPe), and the like. In at least some embodiments, ananatomical structure is defined by its physical structure and aphysiological target is defined by its functional attributes. In atleast one of the various embodiments, the lead may be positioned atleast partially within the target, but in other embodiments, the leadmay be near, but not inside, the target.

Turning to FIG. 1, one embodiment of an electrical stimulation system 10includes one or more stimulation leads 12 and an implantable pulsegenerator (IPG) 14. The system 10 can also include one or more of anexternal remote control (RC) 16, a clinician's programmer (CP) 18, anexternal trial stimulator (ETS) 20, or an external charger 22.

The IPG 14 is physically connected, optionally via one or more leadextensions 24, to the stimulation lead(s) 12. Each lead carries multipleelectrodes 26 arranged in an array. The IPG 14 includes pulse generationcircuitry that delivers electrical stimulation energy in the form of,for example, a pulsed electrical waveform (i.e., a temporal series ofelectrical pulses) to the electrode array 26 in accordance with a set ofstimulation parameters. The IPG 14 can be implanted into a patient'sbody, for example, below the patient's clavicle area or within thepatient's buttocks or abdominal cavity. The IPG 14 can have eightstimulation channels which may be independently programmable to controlthe magnitude of the current stimulus from each channel. In at leastsome embodiments, the IPG 14 can have more or fewer than eightstimulation channels (for example, 4-, 6-, 16-, 32-, or more stimulationchannels). The IPG 14 can have one, two, three, four, or more connectorports, for receiving the terminals of the leads.

The ETS 20 may also be physically connected, optionally via thepercutaneous lead extensions 28 and external cable 30, to thestimulation leads 12. The ETS 20, which may have similar pulsegeneration circuitry as the IPG 14, also delivers electrical stimulationenergy in the form of, for example, a pulsed electrical waveform to theelectrode array 26 in accordance with a set of stimulation parameters.One difference between the ETS 20 and the IPG 14 is that the ETS 20 isoften a non-implantable device that is used on a trial basis after theneurostimulation leads 12 have been implanted and prior to implantationof the IPG 14, to test the responsiveness of the stimulation that is tobe provided. Any functions described herein with respect to the IPG 14can likewise be performed with respect to the ETS 20. In at least someembodiments, the ETS can be connected to an external electrode (forexample, a patch, or plate) or to the surgical equipment (for example,frame, cannula, etc.) to serve as a return electrode for the purposesof, for example, monopolar stimulation.

The RC 16 may be used to telemetrically communicate with or control theIPG 14 or ETS 20 via a uni- or bi-directional wireless communicationslink 32. Once the IPG 14 and neurostimulation leads 12 are implanted,the RC 16 may be used to telemetrically communicate with or control theIPG 14 via a uni- or bi-directional communications link 34. Suchcommunication or control allows the IPG 14 to be turned on or off and tobe programmed with different stimulation parameter sets. The IPG 14 mayalso be operated to modify the programmed stimulation parameters toactively control the characteristics of the electrical stimulationenergy output by the IPG 14. The CP 18 allows a user, such as aclinician, the ability to program stimulation parameters for the IPG 14and ETS 20 in the operating room and in follow-up sessions.

The CP 18 may perform this function by indirectly communicating with theIPG 14 or ETS 20, through the RC 16, via a wireless communications link36. Alternatively, the CP 18 may directly communicate with the IPG 14 orETS 20 via a wireless communications link (not shown). The stimulationparameters provided by the CP 18 are also used to program the RC 16, sothat the stimulation parameters can be subsequently modified byoperation of the RC 16 in a stand-alone mode (i.e., without theassistance of the CP 18).

For purposes of brevity, the details of the RC 16, CP 18, ETS 20, andexternal charger 22 will not be further described herein. Details ofexemplary embodiments of these devices are disclosed in U.S. Pat. No.6,895,280, which is expressly incorporated herein by reference. Otherexamples of electrical stimulation systems can be found at U.S. Pat.Nos. 6,181,969; 6,516,227; 6,609,029; 6,609,032; 6,741,892; 7,949,395;7,244,150; 7,672,734; and 7,761,165; 7,974,706; 8,175,710; 8,224,450;and 8,364,278; and U.S. Patent Application Publication No. 2007/0150036,as well as the other references cited above, all of which areincorporated by reference.

FIG. 2 illustrates one embodiment of a lead 100 with electrodes 125disposed at least partially about a circumference of the lead 100 alonga distal end portion of the lead 100 and terminals 135 disposed along aproximal end portion of the lead 100. The lead 100 can be implanted nearor within the desired portion of the body to be stimulated such as, forexample, the brain, spinal cord, or other body organs or tissues. In oneexample of operation for deep brain stimulation, access to the desiredposition in the brain can be accomplished by drilling a hole in thepatient's skull or cranium with a cranial drill (commonly referred to asa burr), and coagulating and incising the dura mater, or brain covering.The lead 100 can be inserted into the cranium and brain tissue with theassistance of a stylet (not shown). The lead 100 can be guided to thetarget location within the brain using, for example, a stereotacticframe and a microdrive motor system. In at least some embodiments, themicrodrive motor system can be fully or partially automatic. Themicrodrive motor system may be configured to perform one or more thefollowing actions (alone or in combination): insert the lead 100,advance the lead 100, retract the lead 100, or rotate the lead 100.

In at least some embodiments, measurement devices coupled to the musclesor other tissues stimulated by the target neurons, or a unit responsiveto the patient or clinician, can be coupled to the IPG 14 or microdrivemotor system. The measurement device, user, or clinician can indicate aresponse by the target muscles or other tissues to the stimulation orrecording electrode(s) to further identify the target neurons andfacilitate positioning of the stimulation electrode(s). For example, ifthe target neurons are directed to a muscle experiencing tremors, ameasurement device can be used to observe the muscle and indicatechanges in, for example, tremor frequency or amplitude in response tostimulation of neurons. Alternatively, the patient or clinician canobserve the muscle and provide feedback.

The lead 100 for deep brain stimulation can include stimulationelectrodes, recording electrodes, or both. In at least some embodiments,the lead 100 is rotatable so that the stimulation electrodes can bealigned with the target neurons after the neurons have been locatedusing the recording electrodes.

Stimulation electrodes may be disposed on the circumference of the lead100 to stimulate the target neurons. Stimulation electrodes may bering-shaped so that current projects from each electrode equally inevery direction from the position of the electrode along a length of thelead 100. In the embodiment of FIG. 2, two of the electrodes 125 arering electrodes 120. Ring electrodes typically do not enable stimuluscurrent to be directed from only a limited angular range around a lead.Segmented electrodes 130, however, can be used to direct stimuluscurrent to a selected angular range around a lead. When segmentedelectrodes are used in conjunction with an implantable pulse generatorthat delivers constant current stimulus, and preferably includesmultiple current sources, current steering can be achieved to moreprecisely deliver the stimulus to a position around an axis of a lead(i.e., radial positioning around the axis of a lead). To achieve currentsteering, segmented electrodes can be utilized in addition to, or as analternative to, ring electrodes.

The lead 100 includes a lead body 110, terminals 135, one or more ringelectrodes 120, and one or more sets of segmented electrodes 130 (or anyother combination of electrodes). The lead body 110 can be formed of abiocompatible, non-conducting material such as, for example, a polymericmaterial. Suitable polymeric materials include, but are not limited to,silicone, polyurethane, polyurea, polyurethane-urea, polyethylene, orthe like. Once implanted in the body, the lead 100 may be in contactwith body tissue for extended periods of time. In at least someembodiments, the lead 100 has a cross-sectional diameter of no more than1.5 mm and may be in the range of 0.5 to 1.5 mm. In at least someembodiments, the lead 100 has a length of at least 10 cm and the lengthof the lead 100 may be in the range of 10 to 70 cm.

The electrodes 125 can be made using a metal, alloy, conductive oxide,or any other suitable conductive biocompatible material. Examples ofsuitable materials include, but are not limited to, platinum, platinumiridium alloy, iridium, titanium, tungsten, palladium, palladiumrhodium, or the like. Preferably, the electrodes 125 are made of amaterial that is biocompatible and does not substantially corrode underexpected operating conditions in the operating environment for theexpected duration of use.

Each of the electrodes 125 can either be used or unused (OFF). When anelectrode is used, the electrode can be used as an anode or cathode andcarry anodic or cathodic current. In some instances, an electrode mightbe an anode for a period of time and a cathode for a period of time.

Deep brain stimulation leads may include one or more sets of segmentedelectrodes. Segmented electrodes may provide for superior currentsteering than ring electrodes because target structures in deep brainstimulation are not typically symmetric about the axis of the distalelectrode array. Instead, a target may be located on one side of a planerunning through the axis of the lead. Through the use of a radiallysegmented electrode array (“RSEA”), current steering can be performednot only along a length of the lead but also around a circumference ofthe lead. This provides precise three-dimensional targeting and deliveryof the current stimulus to neural target tissue, while potentiallyavoiding stimulation of other tissue. Examples of leads with segmentedelectrodes include U.S. Pat. Nos. 8,473,061; 8,571,665; and 8,792,993;U.S. Patent Application Publications Nos. 2010/0268298; 2011/0005069;2011/0130803; 2011/0130816; 2011/0130817; 2011/0130818; 2011/0078900;2011/0238129; 2012/0016378; 2012/0046710; 2012/0071949; 2012/0165911;2012/197375; 2012/0203316; 2012/0203320; 2012/0203321; 2013/0197424;2013/0197602; 2014/0039587; 2014/0353001; 2014/0358208; 2014/0358209;2014/0358210; 2015/0045864; 2015/0066120; 2015/0018915; 2015/0051681;U.S. patent application Ser. Nos. 14/557,211 and 14/286,797; and U.S.Provisional Patent Application Ser. No. 62/113,291, all of which areincorporated herein by reference.

FIG. 3 illustrates one embodiment of a system for practicing theinvention. The system can include a computing device 300 or any othersimilar device that includes a processor 302 and a memory 304, a display306, an input device 308, and, optionally, an electrical stimulationsystem 312. The system 300 may also optionally include one or moreimaging systems 310.

The computing device 300 can be a computer, tablet, mobile device, orany other suitable device for processing information. The computingdevice 300 can be local to the user or can include components that arenon-local to the computer including one or both of the processor 302 ormemory 304 (or portions thereof). For example, in at least someembodiments, the user may operate a terminal that is connected to anon-local computing device. In other embodiments, the memory can benon-local to the user.

The computing device 300 can utilize any suitable processor 302 and theterm “a processor” can include one or more hardware processors withinthe computing device or other components of the system or may be localto the user or non-local to the user or other components of thecomputing device. The processor 302 is configured to executeinstructions provided to the processor 302, as described below.

Any suitable memory 304 can be used for the computing device 302. Thememory 304 illustrates a type of computer-readable media, namelycomputer-readable storage media. Computer-readable storage media mayinclude, but is not limited to, nonvolatile, non-transitory, removable,and non-removable media implemented in any method or technology forstorage of information, such as computer readable instructions, datastructures, program modules, or other data. Examples ofcomputer-readable storage media include RAM, ROM, EEPROM, flash memory,or other memory technology, CD-ROM, digital versatile disks (“DVD”) orother optical storage, magnetic cassettes, magnetic tape, magnetic diskstorage or other magnetic storage devices, or any other medium which canbe used to store the desired information and which can be accessed by acomputing device.

Communication methods provide another type of computer readable media;namely communication media. Communication media typically embodiescomputer-readable instructions, data structures, program modules, orother data in a modulated data signal such as a carrier wave, datasignal, or other transport mechanism and include any informationdelivery media. The terms “modulated data signal,” and “carrier-wavesignal” includes a signal that has one or more of its characteristicsset or changed in such a manner as to encode information, instructions,data, and the like, in the signal. By way of example, communicationmedia includes wired media such as twisted pair, coaxial cable, fiberoptics, wave guides, and other wired media and wireless media such asacoustic, RF, infrared, and other wireless media.

The display 306 can be any suitable display device, such as a monitor,screen, display, or the like, and can include a printer. The inputdevice 308 can be, for example, a keyboard, mouse, touch screen, trackball, joystick, voice recognition system, or any combination thereof, orthe like.

One or more imaging systems 310 can be used including, but not limitedto, MRI, computed tomography (CT), ultrasound, or other imaging systems.The imaging system 310 may communicate through a wired or wirelessconnection with the computing device 300 or, alternatively oradditionally, a user can provide images from the imaging system 310using a computer-readable medium or by some other mechanism.

The electrical stimulation system 312 can include, for example, any ofthe components illustrated in FIG. 1. The electrical stimulation system312 may communicate with the computing device 300 through a wired orwireless connection or, alternatively or additionally, a user canprovide information between the electrical stimulation system 312 andthe computing device 300 using a computer-readable medium or by someother mechanism. In at least some embodiments, the computing device 300may include part of the electrical stimulation system, such as, forexample, the IPG 14, CP 18, RC 16, ETS 20, or any combination thereof.

The methods and systems described herein may be embodied in manydifferent forms and should not be construed as limited to theembodiments set forth herein. Accordingly, the methods and systemsdescribed herein may take the form of an entirely hardware embodiment,an entirely software embodiment or an embodiment combining software andhardware aspects. Systems referenced herein typically include memory andtypically include methods for communication with other devices includingmobile devices. Methods of communication can include both wired andwireless (for example, RF, optical, or infrared) communications methodsand such methods provide another type of computer readable media; namelycommunication media. Wired communication can include communication overa twisted pair, coaxial cable, fiber optics, wave guides, or the like,or any combination thereof. Wireless communication can include RF,infrared, acoustic, near field communication, Bluetooth™, or the like,or any combination thereof.

Stimulation therapy can be used to treat a number of diseases,disorders, and conditions including, but not limited to, pain,Parkinson's Disease, Alzheimer's Disease, essential tremor, epilepsy,dystonia, depression, obsessive-compulsive disorder, addiction,Tourette's syndrome, eating disorders (such as anorexia, bulimia, orobesity), other neurological diseases and disorders, or the like. Toprovide a stimulation therapy, the stimulation parameters for thetherapy may be determined during a programming session. In at least someembodiments, in a programming session a clinician will vary stimulationparameters and measure the resulting stimulation effects or sideeffects. For example, a score can be associated with any stimulationeffect or side effect associated with the set of stimulation parameters.For example, in a patient afflicted with Parkinson's Disease, the scoremay be based on any suitable rating scale (for example, the UnifiedParkinson's Disease Rating Scale (UPDRS)).

In many electrical stimulation systems, cathodic stimulation is used tostimulate patient tissue. Cathodic stimulation is known topreferentially activate neural fibers near the cathode or cathodes. Incontrast to cathodic stimulation, anodic stimulation (e.g., stimulationnear an anode) can activate different neural elements, such as neuralcells. Moreover, the threshold for stimulation of many neural elementsis different for anodic and cathodic stimulation. As an example, U.S.Pat. No. 6,560,490, incorporated herein by reference in its entirety,demonstrates in FIGS. 1 and 2 that cathodic stimulation activates nervefibers at much lower stimulation amplitudes than neuronal cells. Incontrast, anodic stimulation activates neuronal cells at lowerstimulation amplitudes than nerve fibers.

Because anodic stimulation activates neural tissue differently fromcathodic stimulation, it may be difficult to know which type ofstimulation may best produce desired therapeutic effects or best avoidundesirable side-effects. Systems can be programmed with methods tofacilitate selection of beneficial programming using cathodic or anodicstimulation or any combination thereof. Embodiment of such systems caninclude, for example, the system illustrated in FIG. 3, the CP 18 or RC16 of FIG. 1, or any other suitable system or device.

In many instances, for monopolar cathodic stimulation, the anode of theelectrical stimulation system is located on the case of the implantablepulse generator or at another site relatively distant from the cathodeor cathodes on the lead. Monopolar cathodic stimulation may also includeinstances where the anode is distributed over a large number of (forexample, at least four, five, six, seven, or more) electrodes on thelead or where the anode is positioned on the lead at a substantialdistance away from the cathode (for example, the anode is near theproximal end of the array of electrodes and the cathode is near theproximal end of the electrodes.) Similarly, monopolar anodic stimulationmay include instances where the cathode of the electrical stimulationsystem is located on the case of the implantable pulse generator or atanother site relatively distant from the anode or anodes on the lead orinstances where the cathode is distributed over a large number of (forexample, at least four, five, six, seven, or more) electrodes on thelead or where the cathode is positioned on the lead at a substantialdistance away from the anode (for example, the anode is near theproximal end of the array of electrodes and the cathode is near theproximal end of the electrodes.) Another method for identifying theanodic or cathodic nature of stimulation can be found in U.S. Pat. No.8,190,250, incorporated herein by reference in its entirety, whichobserves the angle of an electric field at particular points withrespect to the lead.

FIG. 4A illustrates one method of selecting stimulation parameters foran electrical stimulation system. In step 402, responses are receivedfor multiple monopolar stimulations performed using a subset of one ormore electrodes of a lead as a cathode for each of the monopolarstimulations. In at least some embodiments, other stimulationparameters, such as stimulation amplitude, pulse width, and pulseduration, may be the same for all of the stimulations. In otherembodiments, other stimulation parameters, such as stimulationamplitude, pulse width, and pulse duration, may be different for atleast some of the stimulations. For example, if a particular stimulationis painful or generates unacceptable side effects, the stimulationamplitude may be reduced and stimulation using the same electrode(s) maybe performed with the reduced stimulation amplitude.

The responses to stimulation can be any quantitative or qualitativeassessment of the stimulation itself, one or more therapeutic effects,or one or more side-effects, or any combination thereof. For example,the response may include a rating of the stimulation itself on a scaleof numbers or qualitative scale (e.g., ineffective, good, poor,unacceptable). As another example, the response may include a rating ofone or more beneficial therapeutic effects or side-effects on a scale ofnumbers or qualitative scale. If more than one effect is rated, therating may be an overall rating or there may be multiple ratings foreach effect. The response may be from the programmer or other cliniciandirecting the stimulations or from the patient or from one or moresensors or other device that monitor the patient or from any combinationof these sources.

In step 404, the responses are evaluated and, based on the responses,one or more electrodes are selected for cathodic stimulation. Anysuitable criteria can be used. For example, the electrode(s) whichprovided the most beneficial therapeutic effect may be selected. Asanother example, the electrode(s) that provided the most beneficialtherapeutic effect with no side-effects (or with side-effects below aselected threshold) may be selected.

In step 406, responses are received for multiple monopolar stimulationsperformed using a subset of one or more electrodes of a lead as an anodefor each of the monopolar stimulations. The responses may be assessedusing the same or a different assessment as those in step 402. In someembodiments, the stimulation parameters used for the stimulations ofstep 402 are also used in step 406. In other embodiments, differentstimulation parameters (for example, a different stimulation amplitude,pulse width, or pulse duration, or any combination thereof) may be useddue to the differences in neural activation between anodic and cathodicstimulation.

The monopolar stimulations in steps 402 and 406 may be performed in anyorder and may be intermingled. For example, the monopolar stimulationsin step 402 may be performed first followed by the monopolarstimulations in step 406. In another example, the monopolar stimulationsin step 406 may be performed first followed by the monopolarstimulations in step 402. In yet another example, one or more monopolarstimulations in step 402 may be performed followed by one or moremonopolar stimulations in step 406 followed by further monopolarstimulation(s) in step 402, and so on. For example, cathodic stimulationusing a particular subset of one or more electrodes can be performed instep 402 followed by anodic stimulation using the same subset of one ormore electrodes in step 406 and this pattern can be repeated formultiple different subsets of one or more electrodes.

In step 408, these responses are evaluated and, based on the responses,one or more electrodes are selected for anodic stimulation. The criteriaused for selecting the one or more electrodes may be the same ordifferent as those in step 404.

In some embodiments, the steps 406′ and 408′ of FIG. 4B can be added oneor more times after step 408. In step 406′, responses are received formultiple bipolar or multipolar stimulations utilizing both anodic andcathodic stimulation (i.e., cathodic/anodic stimulation). In step 408′,these responses are evaluated and, based on the responses, one or moreelectrodes are selected for cathodic/anodic stimulation. In suchinstances, multiple electrodes (one or more anodes and one or morecathodes) will be used to provide the stimulation. For example, steps406′ and 408′ may be performed using a combination of 50% anodic and 50%cathodic stimulation, or 25% anodic and 75% cathodic, or any othercombination. Steps 406′ and 408′ may be performed one, two, three, four,or more times using different relative amounts of anodic and cathodicstimulation. It will be understood that that the relative strengths ofanode and cathode on the lead can be different, and this may beaccomplished by putting some current of one polarity at the case orhousing of the IPG (or other distant location). The sum of the currentsfor a given polarity must be equal to the sum of the currents for theother polarity.

Returning to FIG. 4A, in step 410, the selected electrode(s) of step 404or the selected electrode(s) of step 408 (or, optionally, any selectedelectrode(s) from one or more instances of step 408′ of FIG. 4B) isselected as programming electrode(s). Any criteria can be used forselecting between the electrode(s) identified in steps 404 and 408 (and,optionally, any selected electrode(s) from one or more instances of step408′ of FIG. 4B). For example, the electrode(s) which provided the mostbeneficial therapeutic effect may be selected. As another example, theelectrode(s) that provided the most beneficial therapeutic effect withno side-effects (or with side-effects below a selected threshold) may beselected.

In step 412, responses are received for stimulations performed using theprogramming electrode(s) selected in step 410 at a series of differentstimulation amplitudes.

In step 414, a programming stimulation amplitude is selected based onthe responses received in step 412. Any criteria can be used forselecting the programming stimulation amplitude. For example, thestimulation amplitude that provided the most beneficial therapeuticeffect with no side-effects (or with side-effects below a selectedthreshold) may be selected.

In some embodiments, steps 412 and 414 may be repeated for otherstimulation parameters in place of stimulation amplitude. For example,in some embodiments, steps 412 and 414 may be repeated for pulse widthinstead of stimulation amplitude. In some embodiments, steps 412 and 414may be repeated for pulse duration or pulse rate instead of stimulationamplitude. Any subset of additional stimulation parameters may betitrated and selected using the procedure of steps 412 and 414;typically, with previously selected stimulation parameters being held attheir selected value.

In step 416, the system is directed to program the implantable pulsegenerator. In at least some embodiments, this direction may be automaticupon selecting the electrodes and stimulation amplitude (and,optionally, other stimulation parameter(s)). In some embodiments, thedirection is made by a clinician, programmer, or other user.

In step 418, a signal is initiated by the system to program theimplantable pulse generator with stimulation parameters including theprogramming electrode(s) and programming stimulation amplitude (and,optionally, other stimulation parameter(s)). The implantable pulsegenerator can then use this programming to stimulate the patient throughthe attached lead and electrodes.

FIG. 5A illustrates one method of selecting stimulation parameters foran electrical stimulation system. In step 502, responses are receivedfor multiple first stimulations performed using different subsets of oneor more electrodes of a lead. The first stimulations are selected topreferentially stimulate a first type of neural element. Examples typesof neural elements include fibers, cells, neuron terminals, synapses, orneurons with different biophysical properties (such as specific ionchannel properties), or the like. Other types may be more specificincluding, for example, large fibers small fibers, specific types ofcells, and the like. The type of neural element may be based on thetrajectory of the neural element relative to the lead. For example, onetype may be fibers aligned parallel to the lead and another type may befibers aligned perpendicular to the lead. Such trajectories may bedefined by ranges of angles or other geometrical properties.

Preferential stimulation may be based on a variety of factors such as,for example, the geometry of the electrodes (for example, usingelectrodes near tissue having a relatively high concentration of theparticular neural element) or may include stimulation polarity (forexample, anodic or cathodic), pulse width, pulse rate, stimulationamplitude, or other electrical factors. As example, cathodic stimulationmay activate fibers preferentially with respect to neural cells.Conversely, anodic stimulation may activate neural cells preferentiallywith respect to fibers.

In at least some embodiments, other stimulation parameters, such asstimulation amplitude, pulse width, and pulse duration, may be the samefor all of the stimulations. In other embodiments, other stimulationparameters, such as stimulation amplitude, pulse width, and pulseduration, may be different for at least some of the stimulations. Forexample, if a particular stimulation is painful or generatesunacceptable side effects, the stimulation amplitude may be reduced andstimulation using the same electrode(s) may be performed with thereduced stimulation amplitude.

The responses to stimulation can be any quantitative or qualitativeassessment of the stimulation itself, one or more therapeutic effects,or one or more side-effects, or any combination thereof. For example,the response may include a rating of the stimulation itself on a scaleof numbers or qualitative scale (e.g., ineffective, good, poor,unacceptable). As another example, the response may include a rating ofone or more beneficial therapeutic effects or side-effects on a scale ofnumbers or qualitative scale. If more than one effect is rated, therating may be an overall rating or there may be multiple ratings foreach effect. The response may be from the programmer or other cliniciandirecting the stimulations or from the patient or from one or moresensors or other device that monitor the patient or from any combinationof these sources.

In step 504, the responses are evaluated and, based on the responses,one or more electrodes are selected for preferential stimulation of thefirst type of neural element. Any suitable criteria can be used. Forexample, the electrode(s) which provided the most beneficial therapeuticeffect may be selected. As another example, the electrode(s) thatprovided the most beneficial therapeutic effect with no side-effects (orwith side-effects below a selected threshold) may be selected.

In step 506, responses are received for multiple second stimulationsperformed using different subsets of one or more electrodes of a lead.The second stimulations are selected to preferentially stimulate asecond type of neural element that is different from the first type ofneural element. The responses may be assessed using the same or adifferent assessment as those in step 502. In some embodiments, thestimulation parameters used for the stimulations of step 502 are alsoused in step 506. In other embodiments, different stimulation parameters(for example, a different stimulation amplitude, pulse width, or pulseduration, or any combination thereof) may be used due to the differencesin neural activation between stimulation of the first and second typesof neural elements.

The monopolar stimulations in steps 502 and 506 may be performed in anyorder and may be intermingled. For example, the stimulations in step 502may be performed first followed by the stimulations in step 506. Inanother example, the stimulations in step 506 may be performed firstfollowed by the stimulations in step 502. In yet another example, one ormore stimulations in step 502 may be performed followed by one or morestimulations in step 506 followed by further stimulation(s) in step 502,and so on. For example, preferential stimulation of the first type ofneural element using a particular subset of one or more electrodes canbe performed in step 502 followed by preferential stimulation of thesecond type of neural element using the same subset of one or moreelectrodes in step 506 and this pattern can be repeated for multipledifferent subsets of one or more electrodes.

In step 508, these responses are evaluated and, based on the responses,one or more electrodes are selected for preferential stimulation of thesecond type of neural element. The criteria used for selecting the oneor more electrodes may be the same or different as those in step 504.

In some embodiments, the steps 506′ and 508′ of FIG. 5B can be performedone, two, three, or more times after step 508. In step 506′, responsesare received for multiple third (or fourth, fifth, . . . ) stimulationsperformed using different subsets of one or more electrodes of a lead.The third (or fourth, fifth, . . . ) stimulations are selected topreferentially stimulate a third (or fourth, fifth, . . . ) type ofneural element that is different from the first and second (and anyother previously selected) types of neural element. The responses may beassessed using the same or different assessment as those in step 502. Instep 508′, these responses are evaluated and, based on the responses,one or more electrodes are selected for the stimulation of the third (orfourth, fifth, . . . ) type of neural element. The criteria used forselecting the one or more electrodes may be the same or different asthose in step 504.

Returning to FIG. 5A, in step 510, the selected electrode(s) of step 504or the selected electrode(s) of step 508 (or, optionally, any selectedelectrode(s) from one or more instances of step 508′ of FIG. 5B) isselected as programming electrode(s). Any criteria can be used forselecting between the electrode(s) identified in steps 504 and 508 (and,optionally, any selected electrode(s) from one or more instances of step508′ of FIG. 5B). For example, the electrode(s) which provided the mostbeneficial therapeutic effect may be selected. As another example, theelectrode(s) that provided the most beneficial therapeutic effect withno side-effects (or with side-effects below a selected threshold) may beselected.

In step 512, responses are received for stimulations performed using theprogramming electrode(s) selected in step 510 at a series of differentstimulation amplitudes.

In step 514, a programming stimulation amplitude is selected based onthe responses received in step 512. Any criteria can be used forselecting the programming stimulation amplitude. For example, thestimulation amplitude that provided the most beneficial therapeuticeffect with no side-effects (or with side-effects below a selectedthreshold) may be selected.

In some embodiments, steps 512 and 514 may be repeated for otherstimulation parameters in place of stimulation amplitude. For example,in some embodiments, steps 512 and 514 may be repeated for pulse widthinstead of stimulation amplitude. In some embodiments, steps 512 and 514may be repeated for pulse duration or pulse rate instead of stimulationamplitude. Any subset of additional stimulation parameters may betitrated and selected using the procedure of steps 512 and 514;typically, with previously selected stimulation parameters being held attheir selected value.

In step 516, the system is directed to program the implantable pulsegenerator. In at least some embodiments, this direction may be automaticupon selecting the electrodes and stimulation amplitude (and,optionally, other stimulation parameter(s)). In some embodiments, thedirection is made by a clinician, programmer, or other user.

In step 518, a signal is initiated by the system to program theimplantable pulse generator with stimulation parameters including theprogramming electrode(s) and programming stimulation amplitude (and,optionally, other stimulation parameter(s)). The implantable pulsegenerator can then use this programming to stimulate the patient throughthe attached lead and electrodes.

FIG. 6A illustrates one method of selecting stimulation parameters foran electrical stimulation system. In step 602, responses are receivedfor multiple monopolar cathodic stimulations performed using differentfirst sets of stimulation parameters. Each of the cathodic stimulationsuses a subset of one or more electrodes of a lead as a cathode as partof the first set of stimulation parameters. The responses to stimulationcan be any quantitative or qualitative assessment of the stimulationitself, one or more therapeutic effects, or one or more side-effects, orany combination thereof. For example, the response may include a ratingof the stimulation itself on a scale of numbers or qualitative scale(e.g., ineffective, good, poor, unacceptable). As another example, theresponse may include a rating of one or more beneficial therapeuticeffects or side-effects on a scale of numbers or qualitative scale. Ifmore than one effect is rated, the rating may be an overall rating orthere may be multiple ratings for each effect. The response may be fromthe programmer or other clinician directing the stimulations or from thepatient or from one or more sensors or other device that monitor thepatient or from any combination of these sources.

In step 604, responses are received for multiple monopolar anodicstimulations performed using different second sets of stimulationparameters as part of the first set of stimulation parameters. Each ofthe anodic stimulations uses a subset of one or more electrodes of alead as an anode. The responses may be assessed using the same or adifferent assessment as those in step 602.

The monopolar stimulations in steps 602 and 604 may be performed in anyorder and may be intermingled. For example, the monopolar stimulationsin step 602 may be performed first followed by the monopolarstimulations in step 604. In another example, the monopolar stimulationsin step 604 may be performed first followed by the monopolarstimulations in step 602. In yet another example, one or more monopolarstimulations in step 602 may be performed followed by one or moremonopolar stimulations in step 604 followed by further monopolarstimulation(s) in step 602, and so on. For example, cathodic stimulationusing a particular subset of one or more electrodes can be performed instep 602 followed by anodic stimulation using the same subset of one ormore electrodes in step 604 and this pattern can be repeated formultiple different subsets of one or more electrodes.

In some embodiments, the step 604′ of FIG. 6B can be added one or moretimes after step 604. In step 604′, responses are received for multiplebipolar or multipolar stimulations utilizing both anodic and cathodicstimulation (i.e., cathodic/anodic stimulation). For example, step 604′may be performed using a combination of 50% anodic and 50% cathodicstimulation, or 25% anodic and 75% cathodic, or any other combination.Step 604′ may be performed one, two, three, four, or more times usingdifferent relative amounts of anodic and cathodic stimulation. It willbe understood that that the relative strengths of anode and cathode onthe lead can be different, and this may be accomplished by putting somecurrent of one polarity at the case or housing of the IPG (or otherdistant location). The sum of the currents for a given polarity must beequal to the sum of the currents for the other polarity.

Returning to FIG. 6A, in step 606, one of the sets of first or second(or, optionally, third, fourth, fifth, . . . ) stimulation parameters isselected as a program set of stimulation parameters. Any criteria can beused for selecting between the sets of first or second (or, optionally,third, fourth, fifth, . . . ) stimulation parameters. For example, theset of stimulation parameters which provided the most beneficialtherapeutic effect may be selected. As another example, the set ofstimulation parameters that provided the most beneficial therapeuticeffect with no side-effects (or with side-effects below a selectedthreshold) may be selected.

In step 608, the system is directed to program the implantable pulsegenerator. In at least some embodiments, this direction may be automaticupon selecting the set of program stimulation parameters. In someembodiments, the direction is made by a clinician, programmer, or otheruser.

In step 610, a signal is initiated by the system to program theimplantable pulse generator with set of program stimulation parameters.The implantable pulse generator can then use this programming tostimulate the patient through the attached lead and electrodes.

During programming sessions, as well as at other times, it can behelpful to visualize the region that will be stimulated. Stimulationregion visualization systems and methods can be used to predict orestimate a region of stimulation for a given set of stimulationparameters. In at least some embodiments, the systems and methodsfurther permit a user to modify stimulation parameters and visuallyobserve how such modifications can change the predicted or estimatedstimulation region. Such algorithms and systems may provide greater easeof use and flexibility and may enable or enhance stimulation therapy.The terms “stimulation field map” (SFM), “volume of activation” (VOA),or “volume of tissue activated (VTA)” are often used to designate anestimated region of tissue that will be stimulated for a particular setof stimulation parameters. Any suitable method for determining theVOA/SFM/VTA can be used including those described in, for example, U.S.Pat. Nos. 8,326,433; 8,379,952; 8,649,845; 8,675,945; 8,831,731;8,849,632; 8,855,773; 8,913,804; 8,918,183; 8,958,615; 9,026,317;9,050,470; 9,072,905; 9,081,488; 9,084,896; 9,135,400; 9,235,685;9,254,387; 9,227,074; 9,272,153; 9,302,110; 9,308,372; 9,310,985;9,364,665; 9,526,902; 9,586,053; 9,792,412; 9,821,167; 9,925,382; and9,959,940; U.S. Patent Application Publications Nos. 2009/0287272;2009/0287273; 2012/0314924; 2013/0116744; 2014/0122379; and2015/0066111; U.S. patent applications Ser. Nos. 15/706,004 and15/937,264; and U.S. Provisional Patent Applications Ser. Nos.62/030,655 and 62/532,869, all of which are incorporated herein byreference in their entireties.

In at least some embodiments, as a precursor or during any of themethods described above (including those methods described using theflowcharts of FIGS. 4A to 6B), a set of stimulation parameters or a setof electrodes may be determined or suggested using a VOA/SFM/VTAvisualization system. In at least some embodiments, a system, such as,for example, the system illustrated in FIG. 3, the CP 18 or RC 16 ofFIG. 1, or any other suitable system or device, can be configured todetermine, visualize, or otherwise use VOAs/SFMs/VTAs. In addition tothe references cited above, other methods and systems for visualizationof VOAs/SFMs/VTAs for anodic and cathodic stimulation are described inU.S. Provisional Patent Application No. 62/663,895 entitled “Systems andMethods for Visualizing and Programming Electrical Stimulation”,Attorney Docket No. BSNC-1-699.0, filed on even date herewith, which isincorporated herein by reference in its entirety.

FIG. 7 is a flowchart of one embodiment of a method of determining orsuggesting a set of stimulation parameters or electrodes. In step 702, atarget volume of neural elements is identified. Any suitable method ofidentification can be used including, but not limited to, methods andsystems described in any of the references cited above and U.S. Pat.Nos. 8,379,952; 8,649,845; 8,831,731; 8,855,773; 8,913,804; 8,918,183;9,026,317; 9,050,470; 9,072,905; 9,081,488; 9,084,896; 9,135,400;9,227,074; 9, 235,685; 9,254,387; 9,272,153; 9,302,110; 9,308,372;9,310,985; 9,364,665; 9,526,902; 9,586,053; 9,792,412; 9,821,167;9,925,382; and 9,959,940; U.S. Patent Application Publications Nos.2016/0375248; 2016/0375258; and 2017/0304633; U.S. patent applicationsSer. Nos. 15/706,004; 15/864,876; and 15/937,264; and U.S. ProvisionalPatent Applications Ser. Nos. 62/030,655 and 62/532,869, all of whichare incorporated herein by reference in their entireties.

In step 704, a VOA (or SFM or VTA) is determined that approximates orencompasses the target volume (or at least a threshold amount of thetarget volume). In at least some embodiments, this determination isperformed using a model for the selected type of stimulation (e.g.,cathodic, anodic, cathodic/anodic, fiber, cell, or the like or anycombination thereof). Any suitable method of determination of aVOA/SFM/VTA can be used including, but not limited to, methods andsystems described in any of the references cited above and U.S. Pat.Nos. 8,326,433; 8,379,952; 8,649,845; 8,675,945; 8,831,731; 8,849,632;8,855,773; 8,913,804; 8,918,183; 8,958,615; 9,026,317; 9,050,470;9,072,905; 9,081,488; 9,084,896; 9,135,400; 9,227,074; 9, 235,685;9,254,387; 9,272,153; 9,302,110; 9,308,372; 9,310,985; 9,364,665;9,526,902; 9,586,053; 9,792,412; 9,821,167; 9,925,382; and 9,959,940;U.S. Patent Application Publications Nos. 2009/0287272; 2009/0287273;2012/0314924; 2013/0116744; 2014/0122379; 2015/0066111; 2016/0375248;2016/0375258; and 2017/0304633; U.S. patent applications Ser. Nos.15/706,004; 15/864,876; and 15/937,264; and U.S. Provisional PatentApplications Ser. Nos. 62/030,655 and 62/532,869, all of which areincorporated herein by reference in their entireties.

In step 706, the set of stimulation parameters or set of one or moreelectrodes of the determined VOA/SFM/VTA is obtained. This set ofstimulation parameters or set of one or more electrodes can then be usedin the methods described above as one set to test or may be used as astarting point to produce multiple sets to test. In at least someembodiments, the method illustrated in FIG. 7 may be performed multipletimes for different types of stimulation (e.g., cathodic, anodic,cathodic/anodic, fiber, cell, or the like or any combination thereof).

In at least some embodiments, it is useful to visually graph thestimulation effects (for example, one or more therapeutic effects orside-effects, or any combination thereof) or responses with respect toone or more stimulation parameters such as, for example, electrodeselection, stimulation amplitude, or the like, or any combinationthereof. Any suitable method and arrangement for graphing stimulationeffects can be used including, but not limited to, methods,arrangements, and systems described in U.S. Pat. Nos. 9,227,074;9,358,398; 9,474,903; 9,492,673; 9,643,015; and 9,643,017; U.S. PatentApplication Publications Nos. 2014/0277284 and 2017/0100593; U.S. patentapplications Ser. Nos. 15/631,964 and 15/920,153; and U.S. ProvisionalPatent Application Ser. No. 62/532,869, all of which are incorporatedherein by reference in their entireties.

As an example, one embodiment of a graph includes a two- orthree-dimensional graph with electrode location along one or twodimensions and stimulation amplitude along one or two dimensions.Examples can be found in U.S. Pat. Nos. 9,227,074; 9,358,398; 9,474,903;9,492,673; 9,643,015; and 9,643,017; U.S. Patent ApplicationPublications Nos. 2014/0277284 and 2017/0100593; U.S. patentapplications Ser. Nos. 15/631,964 and 15/920,153; and U.S. ProvisionalPatent Application Ser. No. 62/532,869, all of which are incorporatedherein by reference in their entireties. In some embodiments, an innercircle represents the therapeutic effects and an outer ring representsthe side-effects with a shading, color, or intensity of the inner circleor outer ring representing the score, value, or intensity of the effect.As a modification of this arrangement, for methods or systems evaluatingboth anodic or cathodic stimulation using the same electrode, acorresponding marker might include an inner circle and three concentricrings to represent the therapeutic effects of cathodic stimulation,therapeutic effects of anodic stimulation, side-effects of cathodicstimulation, and side-effects of anodic stimulation in any order. Asanother example of a modification, the inner circle and outer ring maybe split in half with one half representing cathodic stimulation and theother half representing anodic stimulation.

In at least some embodiments, during any of the methods described above(including those methods described using the flowcharts of FIGS. 4A to6B), a graph of responses to stimulation can be generated. In at leastsome embodiments, a system, such as, for example, the system illustratedin FIG. 3, the CP 18 or RC 16 of FIG. 1, or any other suitable system ordevice, can be configured to generate the graph.

FIG. 8 is a flowchart of one embodiment of a method of generating ausing a graph of responses to stimulations. In step 802, a graph ofresponses to the stimulations is generated. Any suitable method,arrangement, or system can be used including, but not limited to, themethods, arrangements, and systems described above in the referencescited above.

In step 804, the graph is used to facilitate selection of a set of oneor more electrodes or set of stimulation parameters. The graph canprovide a useful visualization of the responses to stimulation.

In at least some embodiments, any of the methods described herein,including the methods illustrated in FIGS. 4A to 6B, may be performedmanually. In other embodiments, the methods may be performed using asemi- or wholly automated system. Example of methods for semi- or whollyautomating adjustments to stimulation parameters of electricalstimulation systems can be found at, for example, the references citedabove and U.S. Pat. No. 9,248,280; U.S. Patent Applications PublicationNos. 2016/0136429; 2016/0136443; and 2016/0256693; and U.S. patentapplication Ser. No. 15/783,961, all of which are incorporated herein byreference in their entireties. For example, the system may selectelectrodes and stimulation parameters in automatically or with somefeedback from the patient or clinician. In some embodiments, the systemmay utilize one or more sensors to obtain the response to stimulationand utilize that responses in an automated system to select additionalelectrodes or stimulation parameters to try or in the selection steps ofthe methods described above. The optional sensors can be any suitabletype of sensor including, but not limited to, optical sensors,piezoelectric sensors, chemical sensors, accelerometers, local fieldpotential sensors, evoked compound action potential (eCAP) sensors, orthe like. The sensors may be separate from the implantable pulsegenerator, lead, or other components of the system or may be disposed onthe implantable pulse generator, lead, or other components of thesystem. The sensors may be identical or may be different (for example,different types of sensors or sensors for different types of chemicalsor signals). In at least some embodiments, a sensor can be wire- orwirelessly coupled to an implantable pulse generator, CP, RC, or anyother suitable device using wires, leads, Bluetooth™, rf transmission,or any other suitable transmission arrangement.

In some embodiments, the system may select electrodes or generate newstimulator parameter values using machine learning techniques or anyother suitable methods including, but not limited to, gradient-descent,genetic algorithms, swarm algorithms, statistical algorithms,brute-force searching, or any of the methods described in U.S. patentapplication Ser. No. 15/783,961 or any of the other references citedabove, all of which are incorporated by reference in their entirety.

The programming procedure performed in conventional electricalstimulation (such as deep brain or spinal cord stimulation) is oftenperformed in an initial session and, in at least some instances, atlater sessions. The methods described herein can be used in this manner.

In other embodiments, the methods described herein, including themethods illustrated in FIGS. 4A to 6B, can be used in an automatedfashion in a feedback loop to monitor a patient and adjust stimulationparameters based on current patient responses. In some embodiments, themethods may be performed periodically; for example, every 1, 2, 4, 8, or12 hours, or 1, 2, 4, or 7 days, or 2 or 4 weeks or 1 month or any othersuitable time interval. In some embodiments, alternatively oradditionally, the methods may be performed on user demand for a usersuch as the patient, clinician, or any other suitable individual. Inother embodiments, the methods may be performed continually.

It will be understood that the system can include one or more of themethods described hereinabove with respect to FIGS. 4A to 8 in anycombination. The methods, systems, and units described herein may beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein. Accordingly, the methods, systems,and units described herein may take the form of an entirely hardwareembodiment, an entirely software embodiment or an embodiment combiningsoftware and hardware aspects. The methods described herein can beperformed using any type of processor or any combination of processorswhere each processor performs at least part of the process.

It will be understood that each block of the flowchart illustrations,and combinations of blocks in the flowchart illustrations and methodsdisclosed herein, can be implemented by computer program instructions.These program instructions may be provided to a processor to produce amachine, such that the instructions, which execute on the processor,create means for implementing the actions specified in the flowchartblock or blocks disclosed herein. The computer program instructions maybe executed by a processor to cause a series of operational steps to beperformed by the processor to produce a computer implemented process.The computer program instructions may also cause at least some of theoperational steps to be performed in parallel. Moreover, some of thesteps may also be performed across more than one processor, such asmight arise in a multi-processor computer system. In addition, one ormore processes may also be performed concurrently with other processes,or even in a different sequence than illustrated without departing fromthe scope or spirit of the invention.

The computer program instructions can be stored on any suitablecomputer-readable medium including, but not limited to, RAM, ROM,EEPROM, flash memory or other memory technology, CD-ROM, digitalversatile disks (“DVD”) or other optical storage, magnetic cassettes,magnetic tape, magnetic disk storage or other magnetic storage devices,or any other medium which can be used to store the desired informationand which can be accessed by a computing device.

The above specification provides a description of the structure,manufacture, and use of the invention. Since many embodiments of theinvention can be made without departing from the spirit and scope of theinvention, the invention also resides in the claims hereinafterappended.

What is claimed as new and desired to be protected by Letters Patent ofthe United States is:
 1. A system for programming electrical stimulationof a patient using an implantable electrical stimulation systemcomprising an implantable pulse generator and a lead having a pluralityof electrodes, the system comprising: a processor configured to: receivea first response for each of a plurality of first monopolar stimulationsperformed using a subset of one or more of the electrodes of the lead asa cathode for each of the first monopolar stimulations; select a firstsubset of one or more of the electrodes based on the first responses;receive a second response for each of a plurality of second monopolarstimulations performed using a subset of one or more of the electrodesof the lead as an anode for each of the second monopolar stimulations;select a second subset of one or more of the electrodes based on thesecond responses; select a programming subset of one or more of theelectrodes based, at least in part, on the responses associated with thefirst subset and second subset; receive a third response for each of aplurality of third monopolar stimulations performed using theprogramming subset with each of the third monopolar stimulation having adifferent stimulation amplitude; select a programming stimulationamplitude based on the third responses; receive direction to program theimplantable pulse generator with the programming subset of one or moreof the electrodes and the programming stimulation amplitude; andinitiate a signal that provides the implantable pulse generator of theelectrical stimulation system with the programming subset of one or moreof the electrodes and the programming stimulation amplitude forgenerating electrical stimulation for the patient through the electrodesof the lead.
 2. The system of claim 1, wherein receiving a firstresponse comprises receiving a first quantitative or qualitativeindication of at least one therapeutic effect and receiving a secondresponse comprises receiving a second quantitative or qualitativeindication of at least one therapeutic effect.
 3. The system of claim 1,wherein receiving a first response comprises receiving a firstquantitative or qualitative indication of at least one therapeuticeffect, at least one side-effect, or any combination thereof andreceiving a second response comprises receiving a second quantitative orqualitative indication of at least one therapeutic effect, at least oneside-effect, or any combination thereof.
 4. The system of claim 3,wherein selecting the set of program stimulation parameters comprisesselecting the set of program stimulation parameters based on the firstand second quantitative or qualitative indications.
 5. The system ofclaim 1, wherein the processor is further configured to: receive a thirdresponse for each of a plurality of cathodic/anodic stimulationsperformed using a subset of one or more of the electrodes of the lead asan anode and one or more of the electrodes of the lead as a cathode foreach of the cathodic/anodic stimulations; select a third subset of oneor more of the electrodes based on the third responses; whereinselecting the programming subset of one or more of the electrodescomprises selecting the programming subset of one or more of theelectrodes based, at least in part, on the first, second, and thirdresponses associated with the first subset, second subset, and thirdsubset.
 6. The system of claim 1, wherein receiving a first responsecomprising receiving the first response from a clinician or patient. 7.The system of claim 1, wherein receiving a first response comprisingreceiving the first response from a sensor.
 8. A system for programmingelectrical stimulation of a patient using an implantable electricalstimulation system comprising an implantable pulse generator and a leadhaving a plurality of electrodes, the system comprising: a processorconfigured to: receive a first response for each of a plurality of firststimulations performed using a subset of one or more of the electrodesof the lead for each of the first stimulations, wherein the firststimulations are configured to preferentially stimulate a first type ofneural element; select a first subset of one or more of the electrodesbased, at least in part, on the first responses; receive a secondresponse for each of a plurality of second stimulations performed usinga subset of one or more of the electrodes for each of the secondstimulations, wherein the second stimulations are configured topreferentially stimulate a second type of neural element which isdifferent from the first type of neural element; select a second subsetof one or more of the electrodes based, at least in part, on the secondresponses; select a programming subset of one or more of the electrodesbased on the responses associated with the first subset and secondsubset; receive direction to program the implantable pulse generatorwith the programming subset of one or more of the electrodes and theprogramming stimulation amplitude; and initiate a signal that providesthe implantable pulse generator of the electrical stimulation systemwith the programming subset of one or more of the electrodes and theprogramming stimulation amplitude for generating electrical stimulationfor the patient through the electrodes of the lead.
 9. The system ofclaim 8, wherein receiving a first response comprises receiving a firstquantitative or qualitative indication of at least one therapeuticeffect and receiving a second response comprises receiving a secondquantitative or qualitative indication of at least one therapeuticeffect.
 10. The system of claim 8, wherein receiving a first responsecomprises receiving a first quantitative or qualitative indication of atleast one therapeutic effect, at least one side-effect, or anycombination thereof and receiving a second response comprises receivinga second quantitative or qualitative indication of at least onetherapeutic effect, at least one side-effect, or any combinationthereof.
 11. The system of claim 10, wherein selecting the set ofprogram stimulation parameters comprises selecting the set of programstimulation parameters based on the first and second quantitative orqualitative indications.
 12. The system of claim 8, wherein theprocessor is further configured to: receive a third response for each ofa plurality of third stimulations performed using a subset of one ormore of the electrodes for each of the third stimulations, wherein thethird stimulations are configured to preferentially stimulate a thirdtype of neural element which is different from the first and secondtypes of neural element; select a third subset of one or more of theelectrodes based, at least in part, on the third responses; whereinselecting the programming subset of one or more of the electrodescomprises selecting the programming subset of one or more of theelectrodes based, at least in part, on the first, second, and thirdresponses associated with the first subset, second subset, and thirdsubset.
 13. The system of claim 8, wherein receiving a first responsecomprising receiving the first response from a clinician or patient. 14.The system of claim 8, wherein receiving a first response comprisingreceiving the first response from a sensor.
 15. A system for programmingelectrical stimulation of a patient using an implantable electricalstimulation system comprising an implantable pulse generator and a leadhaving a plurality of electrodes, the system comprising: a processorconfigured to: receive a first response for each of a plurality of firstmonopolar stimulations performed using at least one of the electrodes ofthe lead as a cathode, each of the first monopolar stimulations having aset of first stimulation parameters associated with the firststimulation; receive a second response for each of a plurality of secondmonopolar stimulations performed using at least one of the electrodes ofthe lead as an anode, each of the second monopolar stimulations having aset of second stimulation parameters associated with the secondstimulation; select, from the sets of first stimulation parameters andsets of second stimulation parameters, a set of program stimulationparameters for a first stimulation program based on the first and secondresponses; receive direction to program the implantable pulse generatorwith the set of program stimulation parameters; and initiate a signalthat provides the implantable pulse generator of the electricalstimulation system with the set of program stimulation parameters forgenerating electrical stimulation for the patient through the electrodesof the lead.
 16. The system of claim 15, wherein receiving a firstresponse comprises receiving a first quantitative or qualitativeindication of at least one therapeutic effect and receiving a secondresponse comprises receiving a second quantitative or qualitativeindication of at least one therapeutic effect.
 17. The system of claim15, wherein receiving a first response comprises receiving a firstquantitative or qualitative indication of at least one therapeuticeffect, at least one side-effect, or any combination thereof andreceiving a second response comprises receiving a second quantitative orqualitative indication of at least one therapeutic effect, at least oneside-effect, or any combination thereof.
 18. The system of claim 17,wherein selecting the set of program stimulation parameters comprisesselecting the set of program stimulation parameters based on the firstand second quantitative or qualitative indications.
 19. The system ofclaim 15, wherein receiving a first response comprising receiving thefirst response from a clinician or patient.
 20. The system of claim 15,wherein receiving a first response comprising receiving the firstresponse from a sensor.